ABSTRACT
BACKGROUND/OBJECTIVE: High protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effects of 8 week long consumption of high protein ONS on the renal function of nursing home residents in need of supplementation. Furthermore, within the same setup, differences in gastro-intestinal tolerance between a standard and a more concentrated version of an ONS were investigated. DESIGN: Randomized, controlled, single-blind, parallel-group, multi-country trial (NTR2565). SETTING: Nursing home. PARTICIPANTS: 67 nursing home residents in need of ONS (energy-dense, small volume group n=32; standard volume group n=35). INTERVENTION: Protein supplementation was provided by either a standard (200ml, 300kcal, 20g protein) or an energy-dense, small volume (125ml, 300kcal, 18g protein) ONS during the 8 week long study. MEASUREMENTS: Primary outcome was gastro-intestinal tolerance, assessed by daily stool frequency and consistency, and occurrence and intensity of self-reported gastro-intestinal symptoms. Safety was measured via the occurrence of (serious) adverse events, vital signs, as well as liver- and kidney function monitoring. RESULTS: No clinically relevant and, except for flatulence, no statistically significant differences in gastro-intestinal tolerance were observed between groups. No significant difference between groups was found for estimated glomerular filtration rate (eGFR) and urinary albumin/creatinine ratio at baseline and week 8, nor for the changes from baseline. Adverse events and the changes in monitored renal parameters over the study period did not point to a deterioration of renal function. CONCLUSION: High protein ONS seems to be well-tolerated and safe; there is no indication that it affects renal function in nursing home residents, including patients with stage 3 chronic kidney disease, under the conditions tested. Results did not suggest a difference in the effect on renal function between standard and energy-dense small volume ONS format.
Subject(s)
Dietary Proteins/adverse effects , Gastrointestinal Diseases/chemically induced , Kidney Diseases/chemically induced , Administration, Oral , Adult , Aged , Albuminuria , Creatinine/urine , Dietary Proteins/administration & dosage , Dietary Supplements/adverse effects , Female , Glomerular Filtration Rate , Humans , Male , Middle Aged , Nursing Homes , Renal Insufficiency, Chronic , Single-Blind MethodABSTRACT
Extracts of amaranth (Amaranthus L.), sorghum (Sorghum bicolor L.) and Japanese millet (Echinochloa frumentacea L.) were evaluated for mutagenicity in Salmonella typhimurium strains TA98, TA100 and TA102. All three pseudocereal extracts were also assessed for their antimutagenic properties against the direct mutagens 2-nitrofluorene (2NF) for strain TA98, 3-(5-nitro-2-furyl)acrylic acid (5NFAA) for TA100 and H(2)O(2) for TA102 strain and against the indirect mutagen aflatoxin B(1) (AFB(1)). No mutagenicity was induced by any of the pseudocereal extracts when tested at concentrations as high as 50mg/ml. All three extracts showed similar antimutagenicity against 5NFAA and no antimutagenicity against 2NF. The number of revertants induced by H(2)O(2) extract was inhibited in order amaranth>Japanese milet>sorghum. All extracts were effective in the inhibition of mutagenic activity of aflatoxin B(1). The total polyphenol content as well as the amount of the flavonoids and phenolic acids as main component of polyphenolics were also determined.
